Transcript Slide 1

Leaning Forward!
Emerging Collaborations, Research &
Accreditation
COAPCR Annual Meeting
DIA Convention
June 26, 2013
Boston, MA
www.coapcr.org
Carolynn Thomas Jones, RN, MSPH
President, Consortium of Academic Programs in Clinical Research (CoAPCR)
Faculty, School of Nursing, University of Alabama at Birmingham
Brief Overview:
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Define CoAPCR
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Define: What is clinical
research?
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Present career paths and
stakeholders
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Defining core competencies for
APCR
www.coapcr.org
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Provides a medium for
communication among CRP
educators
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Encourages the development of
academically based CRP
educational programs.
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Fosters inter-institutional
articulation
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Initiates research, study and
discussion relating to the
educational, manpower and
service needs of CRPs.
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Offers a mechanism for
program accreditation
www.coapcr.org
Clinical Research - It’s global.
Number of Clinical Trials- March 2013
What is clinical research and who works in
that “world”?
10,000
250
Compounds
5
1 FDA Approved
Drug
TIME: 15 Years
COST: $1.6 Billion
POTENTIAL STUDENTS
Year 0
Drug
15
Discovery
Target ID
PreClinical
Biochemist
Microbiologist
Geneticists
Molecular Biologist
Pharmacologist
Organic Chemist
Medicinal Chemist
Statistician
MD/PhD
Phase I
Phase II
Phase III
Trials
Trials
Trials
Bioinformatics
Patent attorney
Lawyers
Project Manager
Pharmacologist
Immunologist
MD Specialist
QA/QC
Informatics
Statistician
Toxicologist
Chemist
Biotechnologist
Biotechnologist
Regulatory Affairs
CRCs, PIs
CRO, CRA
Medical Writing
Regulatory
Project Managers
QA/QC Managers
Data Managers
Statistician
Site IRBs
Site Pharmacists
Phase IV
PostMarketing
Manufacturer
Medical Sales
Marketing
Medical Writing
Communication
CRCs, PIs
CRO, CRAs
Project Managers
Data Managers
Statistician
Site IRBs
EMPLOYERS
Gov't
AMC
Indep
Private
MD
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RESEARCH CAREERS
Pharma CROs
Medical Director
Medical Scientists
Biochemists
Biomedical Engineers
Genetic Engineers
Genetic Counselors
Molecular Biologists
Research Pharmacists
Investigator
Process Engineer
Manufacturing
Packaging, Supply Manager
Information Technologist
Quality Analysts
QA Managers
Data Managers
Data Validators
Quality Auditor
Clinical Safety Specialist
Biostatistician
Scientific Writer
Clinical Research Associate
Site Monitor
Clinical Research Coordinator
Research Nurse Manager
Clinical Research Nurse
Regulatory Affairs Coordinator
IRB Specialist
Research Assistant
Research Lab Manager
Research Recruiter
Research Site Educator
Clinical Research Trainer
Project Manager
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STAKEHOLDERS
Employers of Clinical
Research
Professionals
Salary Scales- Clinical Research Careers
Competency-Based Education for Clinical
Research Professionals
From the Literature
1. Shamoo AE, Resnik DB. 2006. Ethical issues for clinical research managers. DIA J.;40:371383.
2. Carter, S. C., Jester, P. M., & Thomas Jones, C. (2007). Issues in clinical research manager
education and training. Research Practitioner, 8(2):48-60
3. Jones CT, Harrison L, Carter S. Education and training preferences of clinical research
managers. 2008. Research Practitioner ; 9(6):201-211.
3. Ekmekci O, Bocchino J, Turley C, Butler J. 2011 Who is a Clinical Research Professional?
Monitor; 25(5):11-20.
4. Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and Training Needs of
Pharmaceutical Physicians in the United States. Monitor; 25(6):9-15.
5. Jones, C.T., Parmentier, J., Sonstein, S., Silva, H., Lubejko, B., Pidd, H., Gladson, B.,
Browning, S. (2012). Defining competencies in clinical research: Issues in clinical
research education. Research Practitioner, 13(3), 99-107.
Educational Modalities Used by
Clinical Research Professionals
On the job training
(Books, Articles)
Employer
Offerings
(CEUs)
Sponsor
Meetings
Private
Offerings
(Project-specific)
(Barnett)
Professional
Organization
Academic
Self Study
(Certification)
continues to be a primary
mode, until something
happens!
(Certificate,
Degrees)
& New Regulatory Requirements
Basic Knowledge Areas
(out of 19)
Training
Needed
Ever Received
Adequate Training
Regulatory Affairs
86
46
Toxicity Testing
63
23
Pharmaceutical Development
62
24
Quality and Audit Issues
63
32
Drug Safety/Pharmacovigilance
82
51
Clinical Pharmacology
69
42
Statistics and Data Management
71
47
GXPs (eg, GCP, GMP, GLP)
81
58
Information Technology
42
22
Ethics and Legal Issues
77
58
Modified from Table 1 of Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and
Training Needs of Pharmaceutical Physicians in the United States. Monitor 25(6):9-15.
Newer Knowledge and Skills
(out of 17)
Training
Needed
Ever Received
Adequate Training
Translational Medicine
86
32
Biotechnology
68
27
Medical Devices
43
18
Globalization
81
25
Knowledge Management
76
26
Critical Thinking
65
30
Medical Writing
58
32
Conflict Management
61
36
Teaching and Training Others
52
31
Media Skills
43
29
Modified from Table 2 of Stonier PD, Naraynassamy C, MacGilchrist KS. 2011. Curricular and
Training Needs of Pharmaceutical Physicians in the United States. Monitor 25(6):9-15.
How can we narrow the learning gaps for clinical research
professionals?
What is the impact of learning gaps on healthcare costs and
public safety ?
Education vs training. Importance of critical thinking!
CoAPCR Competency Development Process
In Tandem!
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APPI
ACRP
NIH-NCRR-CTSA program
NIH Clinical Center – Clinical Research Nursing2010
Oncology Nursing Society
Royal College of Nursing (UK)
Quality and Safety Education for Nurses (QSEN)
IACRN Scopes and Standards
CoAPCR
Jones, C.T., Parmentier, J., Sonstein, S., Silva, H., Lubejko, B., Pidd, H.,
Gladson, B., Browning, S. (2012). Defining competencies in clinical research:
Issues in clinical research education. Research Practitioner, 13(3), 99-107.
CoAPCR Core Competency Domains
1.
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Scientific Concepts and Principles of Research Design
Medical Product Development
Clinical Study Operation and Regulatory Compliance
Ethical Considerations and the Responsible Conduct of
Clinical Research
Clinical Study and Site Management
Data Management and Informatics
Communication of Scientific Data
Professionalism, Teamwork and Leadership
Knowledge
Committee
on Accreditation
(CoA)
Chair, Stephen Sonstein
Skills
Program
Curriculum &
Courses
Attitudes
CoAPCR Mission
The Consortium of Academic Programs in Clinical Research facilitates the
development of high-quality educational programs encompassing all areas
of clinical research that are based in academic credit-granting institutions.
www.coapcr.org
[email protected]